Senior Quality Engineer

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit – an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. Senior Quality Engineer The Opportunity This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical leadership across quality engineering activities. This role drives quality strategy, mentors quality engineers, leads complex investigations and improvement initiatives, and serves as a key partner to Operations leadership in achieving quality, compliance, and business objectives. What You’ll Work On Strategic Quality Leadership Serve as the quality lead for assigned manufacturing operations. Develop and execute quality strategies aligned with business objectives. Identify systemic quality risks and drive sustainable improvements. Technical Leadership Lead complex investigations involving complaints, CAPAs, nonconforming material, deviations, and quality events. Provide guidance and technical oversight for quality engineering activities. Drive application of risk-based decision making and quality engineering principles. Team Leadership and Mentorship Mentor and develop Quality Engineers. Provide coaching and technical guidance to support team growth. Lead quality engineering activities across cross-functional teams. Continuous Improvement Lead high-impact quality improvement initiatives. Utilize data analysis and quality metrics to identify trends and drive actions. Champion operational excellence and quality culture initiatives. Compliance and Regulatory Support Lead interactions supporting internal audits, external audits, and regulatory inspections. Ensure compliance with applicable regulations, standards, and company procedures. Assess quality system effectiveness and recommend improvements. Cross-Functional Influence Partner with Operations, Manufacturing Engineering, Regulatory Affairs, R&D, Supply Chain, and leadership teams. Present quality performance, risks, and recommendations to management. Required Qualifications Bachelor’s degree in Engineering, Science, or related technical field with 5+ years of quality engineering, manufacturing engineering, or related experience; or Master’s degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience. Experience leading complex quality initiatives in a regulated industry. Preferred Qualifications Medical device industry experience. ASQ Certified Quality Engineer (CQE) or equivalent ASQ certification. Demonstrated experience mentoring engineers and leading cross-functional teams. Experience supporting FDA inspections and external audits. Strong knowledge of FDA Quality System Regulation, ISO 13485, CAPA, complaints, risk management, and manufacturing quality systems. Pay The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted. Abbott is an Equal Opportunity Employer, committed to employee diversity. #J-18808-Ljbffr Abbott Laboratories